An evaluation of high-density polyethylene bottles used to package solid oral dosage forms and a determination of the impact of using regrind

Pharmaceutical Technology

Volumn 21, Issue 9, 1997, Pages 116-131

  Taborsky, C Jeanne ^a   Fargher, James M ^b   Johnson, James B ^c   Okeke, Claudia ^d  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Owens Brockway   (United States)

^c PhRMA Packaging Working Group   (United Kingdom)

^d UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

COPOLYMER; POLYETHYLENE; POLYMER; RESIN;

ARTICLE; ASSAY; CONTAINER; DRUG DOSAGE FORM; DRUG MANUFACTURE; PACKAGING MATERIAL; QUALITY CONTROL; THERMAL ANALYSIS;

EID: 0030825684     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington, DC, 1 April, 1977) part 211.94 (a)(b).
2. USP 23 (United States Pharmacopeial Convention, Rockville, MD, 1995).
3. J.T. Reamer et al., "Moisture Permeation of Typical Unit Dose Repackaging Materials," Am. J. Hosp. Pharm. 34, 35-42 (January 1977).
4. J.T. Reamer and L.T. Grady, "Moisture Permeation of Newer Unit Dose Repackaging Materials," Am. J. Hosp. Pharm. 35, 787-793 (July 1978).
5. C.J. Taborsky-Urdinola, V. Gray, and L.T. Grady, "Effects of Packaging and Storage on the Dissolution of Model Prednisone Tablets," Am. J. Hosp. Pharm. 38, 1322-1327 (September 1981).
6. USP, 23d Rev. (United States Pharmacopeial Convention, Rockville, MD, 1995), General Chapters (661) and (671).
7. C. Pattanakul, S. Selke, and J. Miltz, "Properties of Recycled High-Density Polyethylene from Milk Bottles," J. Appl. Polym. Sci. 43, 2147-2150, (1991).
8. F. Mitterhofer, Polym. Eng. Sci., 2, 692.
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11. J. Miltz and M. Narkis, J. Appl. Polym. Sci. 20, 1627 (1976).
12. Pharm. Forum 23 (Sept./Oct. 1997).
13. C. Okeke et al., "Temperature Fluctuations during Mail Order Shipment of Pharmaceutical Articles Using Mean Kinetic Temperature Approach," Pharm. Forum 23 (3), (1997).